Botanical and nutritional therapies for menopausal symptoms have had a rough time over the past few years, as studies called into question the value of popular remedies like soy isoflavones, Black Cohosh and Red Clover. But several new trials are shifting the weight of evidence in favor of Cohosh and soy nuts as beneficial for women during and after menopause.
Black Cohosh, St. John’s Wort Reduce Menopause Symptoms
German researchers just published a prospective, non-randomized, open-label observational study evaluating the use, safety and effectiveness of Black Cohosh (Cimicifuga racemens, aka Actea racemens) alone or in combination with St. John’s Wort (Hypericum perforatum) on menopausal symptoms.
They studied 6,141 women enrolled from 1,287 outpatient gynecology offices who were treated with Remifemin, a standardized Black Cohosh isopropanol extract (1 capsule BID) or Remifemin plus St. John’s Wort (1 or 2 tablets BID) at the discretion of the clinician. The treatment period was two years.
The investigators assessed treatment responses on the Menopause Rating Scale (MRS), an established standard for evaluating menopause symptoms. The primary effectiveness variable was the change in MRS PSYCHE subscore, which includes assessment of depressive mood, nervousness, irritability, impaired performance and memory, from baseline to month three.
Of the enrolled women, 3,027 received the Black Cohosh only, and 3,114 received the Cohosh/St. John’s Wort combination. During the study, 244 women switched from monotherapy to the combination product; 87 women changed from the combination to monotherapy. Women receiving combination therapy had significantly higher baseline PSYCHE scores than those in the monotherapy group. They also had more concomitant disease.
Symptom scores improved in both groups. Changes in the PSYCHE scores were greater in the combination therapy group than in the Cohosh monotherapy group at months three and six. With both treatments, the strongest effects were in reducing hot flashes and night sweats, and these were similar. The effects were evident at month three, and even more so at month six (Briese V, et al. Maturitas. 2007; 57(4): 405–414).
Both treatments were very well tol-erated. The rate of adverse events related to the herbs was very small, at 0.16% or 10 cases. Seven cases were in the Black Cohosh-only group, with three in the combination group.
Comments: The results from this large study support the effectiveness of a Black Cohosh preparation alone or in combination with St. John’s Wort for relief of the most common and bothersome menopausal symptoms such as hot flashes/nightsweats and psychological symptoms. The combination of the two herbs appears to be the best approach for symptoms that include depressive moods, nervousness, irritability, and impaired memory.
Black Cohosh & Breast Cancer Risk Reduction
Further good news for botanical medicine fans: University of Pennsylvania researchers just published a population-based, case-control study showing that routine use of Black Cohosh substantially lowers risk of breast cancer.
They based the findings on analysis of 949 breast cancer cases and 1,524 controls from three counties in the metro Philadelphia area. The women were questioned on their use of herbs containing phytoestrogens or hormone-modulating compounds, including Black Cohosh, Ginseng, and Red Clover.
Overall, 19.2% of the African-American women and 14.7% of the Euro-American women reported that they used herbal medicines for menopausal symptom control.
After adjusting for potential confounding factors, they found that use of Black Cohosh was associated with a 61% reduction in the risk of breast cancer with an odds ratio of 0.39 (95% CI: 0.22–0.70). The breast protective effect was similar for a specific Black Cohosh preparation (Remifemin), which was associated with a 53% reduction (Rebbeck T, et al. Int J Cancer. 2007; 120: 1523–1528).
Comments: This is not the first study that has indicated antiproliferative, antiestrogenic effects of Black Cohosh on breast cancer, especially estrogen receptor (ER)-positive breast cancer. Women included in the current study had first primary invasive breast cancers of stage I, II, III, any grade, and any tissue type (ductal, lobular, mucinous, papillary, mixed). Women with ductal carcinoma in situ or lobular carcinoma in situ were excluded.
The Penn researchers did have pathology reports from 786 of the women who had breast cancers, and they were able to determine tumor hormone receptor status. One of the most interesting findings from this study is that Black Cohosh/Remifemin seemed to have anti-tumor protective effects irrespective of ER status. On the other hand, the effect varied by progesterone receptor (PR) status, showing significant impact in PR positive tumors but not in PR negative tumors. This suggests that PR activity may be related to the protective effects of Black Cohosh on the breast.
They also reported that, contrary to many oncologists’ fears, there were no interactions between Black Cohosh or any of the other herbs the patients were using, and estrogen-modulating anti-cancer drugs like Tamoxifen or Raloxifene.
Though Dr. Rebbeck incorrectly describes Black Cohosh as containing phytoestrogens, this study is, none the less, one more positive finding on the value of Black Cohosh for breast cancer survivors with menopause symptoms.
Soy Nuts Lower BP, Quell Menopause Symptoms
A few handfuls of roasted soy nuts added to a healthy low-fat diet can not only alleviate menopausal symptoms, but also reduce blood pressure, according to a pair of recently published studies by Dr. Francine Welty and colleagues at Beth Israel Deaconess Medical Center, Boston.
The studies involved 60 postmenopausal women who were following the Therapeutic Lifestyle Changes (TLC) diet consisting of no more than 30% total fat (≤7% saturated fat, 15% protein, 55% carbohydrates and <200 mg of cholesterol per day). After 4 weeks on the diet, the women were randomly assigned to either continue the diet alone or to add one half cup of roasted soybeans containing 25 grams of soy protein to their daily intake.
After 8 weeks, both groups were shifted back to the TLC diet alone for 4 weeks, followed by another 8-week crossover period, in which those who initially added soy were instructed to simply continue the diet alone, while those on diet-only in the initial period were asked to add the daily soy nuts.
The soy nuts had a very clear pressure-lowering effect on all the women. Those who were hypertensive at baseline showed a mean of 9.9% decrease in systolic blood pressure and 6.8% in diastolic blood pressure (P < 0.01 for both) while enhancing the TLC diet with daily soy nuts. Women with normal blood pressure at the outset had a mean decrease of 5.3% in systolic blood pressure (P < 0.001) and 2.9% (P = 0.02) in diastolic pressure (Welty FK, et al. Arch Intern Med. 2007; 167: 1060–1067).
Soy also had some significant lipid-related benefits. The hypertensive women showed an 11% reduction in LDL cholesterol and an 8% drop in apolipoprotein B while eating soy nuts daily. The normotensive women did not show this effect.
Dr. Welty and her colleagues also asked the patients to keep a record of their daily hot flashes during each 8-week study period. They found that in women experiencing more than 4.5 hot flashes per day at baseline, the TLC diet plus soy nuts was associated with a 45% decrease in number of hot flashes, when compared to the TLC diet alone.
On average, there were 4.1 hot flashes per day when the women were on TLC plus soy nut versus 7.5 hot flashes per day with the TLC diet alone group. Soy nut intake was also associated with a significant improvement in other menopausal quality of life and psychosocial issues (Welty FK, et al. J Women’s Health. 2007; 16(3): 361–369).
Comments: Dr. Welty’s hypertension report is very encouraging, though there were only 12 hypertensive women in the study. The positive effect of lowering blood pressure adds to the other reported cardiovascular benefits of soy foods that deliver 25 grams per day of soy protein. These have included lowering of total cholesterol and LDL.
Levels of the soy phytoestrogen constituent (isoflavones) are higher in the soy nut supplemented diet and appear to be an easy, and even tasty way of lowering blood pressure. Despite the fact that eating one half cup of soy nuts per day added considerable calories to the womens’ daily intake, the soy-supplemented diet had lower total fat and lower saturated fat.
There are now many studies of different types of soy preparations in the context of menopause, and they have shown inconsistent reductions in menopausal symptoms, whether it be soy foods, soy beverage, soy powders or soy isoflavone capsules/tablets. In this study, which showed a greater degree of relief than has been reported in other studies, it may be that the complex biochemical nature of the whole soy bean, containing a significant amount of protein and isoflavones was responsible for the observed benefit. This study was not blinded, so we cannot rule out a placebo response.
